Lecture - Elan Drug Delivery, Inc. Gainesville, GA R. Wayne...

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G:\REG\C Bauman 2005\Presentation\ADE.ppt 1 1 Elan Drug Delivery, Inc. Gainesville, GA R. Wayne Wiley, R.Ph. Sr. Director, Regulatory Affairs Carl Bauman, R.Ph. Director, Product Safety and Labeling 2 Topics Regulatory History of Pharmacovigilance Post Marketing Adverse Drug Experience (PADE)……. .”Pharmacovigilance” Updates and Additional Information
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G:\REG\C Bauman 2005\Presentation\ADE.ppt 2 3 Objective At the end of today’s session, you should understand the legal and regulatory history and basis for Pharmacovigilance Recognize and understand how to access the regulations regarding Adverse Event Reporting Understand how to successfully complete an FDA AE Report Form and understand the next steps Recognize latest FDA initiatives for PharmacoV 4 In the News BSE/TSE …. . Salmonella / E-Coli Counterfeit Lipitor.….KV Pharma suspends shipments of all FDA approved products Contaminated Heparin and API-GMP (China)
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G:\REG\C Bauman 2005\Presentation\ADE.ppt 3 5 6 Pharmacovigilance Pharmacovigilance (or lack of) has been a major driver of regulatory change throughout history Surveillance and reporting required during Clinical Trials and Post Approval (Marketing) Mandatory Awareness for Regulatory Professional Drug/Device Safety and cGMP compliance (Product Integrity) Legal liability and Application regulatory status are impacted
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G:\REG\C Bauman 2005\Presentation\ADE.ppt 4 7 History Harvey Washington Wiley, MD (1844-1930) Physician and Chemistry Professor at Purdue University Medical School 1883 Named Chief Chemist at Department of Agriculture Outraged by fraud, he conducted investigations of False Drug Claims and Food Adulteration 8 Harvey W. Wiley, MD Chief Chemist Increased public awareness with investigations of unscrupulous use of fillers in Food stuffs (ex Alum & Clay added to poor quality wheat flour to mask taste and increase its weight at sale). Studied toxic effects of questionable chemical preservatives in healthy volunteers Challenged dubious medical claims of tonics and remedies (Patent medicines) The Jungle by Upton Sinclair
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G:\REG\C Bauman 2005\Presentation\ADE.ppt 5 9 1906 Food and Cosmetic Act “Wiley Act” Established FDA Required accurate product labeling Drugs: Required to meet USP & NF standards of Fraud in Drug Claims (partially addressed) Foods: Prohibited addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard or contain decomposed substance (alum/clay) Product weight (if listed on label) must be accurate Authorized FDA to conduct seizure and prosecution 10 Post 1906 Act Era of Drug Standards Dramatic rise 1920-30 in FDA prosecutions and seizure of violative food and drugs District and Supreme court rulings overturn several fraud cases by requiring proof of false claim and intent to defraud Led to increased frustration at FDA
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Lecture - Elan Drug Delivery, Inc. Gainesville, GA R. Wayne...

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